In order to pass a suture through a tubular organ or other structure in a body (a human body or an animal), it is necessary to traverse the bodily structure, tissue or organ completely and encircle the area where the physician or medical technician wishes to place the suture. This traverse and encircle method works well in situations where easy access is available to the structure, tissue or organ and the item to be sutured is easily viewed by the physician. In limited access situations (for example, in laposcopic surgery, cardiac surgery and vascular surgery), the traverse and encirclement by sutures is often times difficult, dangerous and at other times impossible.
As a further example, an attempt to suture a blood vessel through a small puncture wound is almost impossible. The direct suture of the arterial puncture is not possible.
The increasing utilization of minimally invasive surgical techniques has created a need for improved methods, suture systems and suture placement devices under adverse conditions of limited access and limited visibility of the suture site.
U.S. Pat. No. 5,053,046 to Janese discloses a dural sealing needle. The dural sealing needle includes a gelatin sealing compound that swells and sits between an impact cone cavity and an impact cone protrusion. Wings spread out based upon the swelling of the gelatin seal and assist in the retention of the suture seal. U.S. Pat. No. 5,860,990 to Nobles et al. discloses a suturing device which includes sutures having needle points at terminal ends of the suture wire. The sutures are made of NITINOL memory shape metal material. When the memory shape metal is freed from the lumen of a needle, the needle points, at the terminal ends of the metal sutures, flare out laterally beyond the lumen of the needle and the needle points are captured by suture catches which are also laterally disposed outboard of the needle. The catches pull the needle points and draw in the sutures.
U.S. Pat. No. 4,744,364 to Kensey discloses a tubular body at the end of a suture thread which expands after being pushed out from the lumen of a delivery needle. In the lumen, the body is contracted or compressed. U.S. Pat. No. 4,741,330 to Hayhurst discloses an apparatus for anchoring cartilage. The anchor is deformed in the lumen of a delivery tube, is thereafter pushed from the tube and springs laterally outward upon exiting the tube.
U.S. Pat. No. 4,705,040 to Mueller et al. disclose a T-shaped bar, having a length of 0.25 inches, at the end of a suture. The bar is held in place by a melted ball of material at the terminal end of the suture.
It is an object of the present invention to provide a suture which can be self secured on a bodily structure, tissue, organ, bodily substructure or vascular vessel wall with a toggle at the terminal end of the suture.
It is another object of the present invention to provide a generally T-shaped toggle which latches on an interior or inboard surface of a bodily structure, tissue, organ, bodily substructure or vascular vessel wall thereby permitting the balance of the suture to be drawn in and wherein the toggle grasps the bodily structure, tissue, organ, bodily substructure or vascular vessel wall.
It is a further object of the present invention to provide a toggle configured as a bar at the end of a suture.
It is another object of the present invention to provide a metal wire suture with a T-shaped toggle or a toggle wire element attached to the terminal end of a suture wire.
It is a further object of the present invention to provide a suture and a suture toggle wherein the suture toggle includes a protruding leg or tab which is utilized by a needle delivery system to insert the suture toggle into the bodily structure, tissue, organ, bodily substructure or vascular vessel wall.
It is a further object of the present invention to provide a suture delivery system including a slotted needle, within which is seated the leg or tab of the suture toggle, which assists in the process of inserting the suture toggle into the bodily structure, tissue, organ, bodily substructure or vascular vessel wall.
It is another object of the present invention to provide a self-securing suture with a suture toggle which can be used for minimally invasive surgical techniques.
It is another object of the present invention to provide a suture delivery system capable of delivering one or more self-securing sutures with suture toggles and which can be used for minimally invasive surgical techniques.
It is a further object of the present invention to provide a suture delivery system capable of delivering and embedding sutures into a bodily structure, tissue, organ, bodily substructure or vascular vessel wall when access to the suture delivery site is limited to approaching the site at an acute angle.
It is a further object of the present invention to provide a suture delivery system and toggle sutures utilized in laposcopic procedures.
It is a further object of the present invention to provide a suture delivery system which can be safely used to embed sutures into a bodily structure, tissue, organ, bodily substructure or vascular vessel wall during minimally invasive surgical techniques.
It is a further object of the present invention to provide a suture delivery system which can be safely used to set sutures into a bodily structure, tissue, organ, bodily substructure or vascular vessel wall, and which provides the health care provider utilizing the system measured control over the insertion of the sutures into the aforementioned bodily area.
The suture delivery system utilizes two sutures. Each suture has a filament body and a toggle bar. The delivery system includes an elongated central tube with two needle retainer guides and a cam distally disposed on the central tube. The needles have piercing needle ends and each needle end carries a respective toggle bar for a suture disposed thereon. A movable member, longitudinally movably mounted on the central tube, is coupled to the needles. The needles are movably disposed in respective needle retainer guides. An actuator is coupled to the movable member such that when the actuator longitudinally moves the movable member over the central tube, the needles, initially captured by the needle retainer guides, extend outward such that the needle ends move over the cam. In a further embodiment, the actuator includes a first user actuation surface coupled to the movable member and the central tube includes a second user actuation surface which is generally static. In a further embodiment, a locking member disposed on the second user actuation surface can be secured to the first user actuation surface to lock the delivery device with the needles in an extended position. As a further enhancement, each needle end includes a slot to capture the respective toggle bar thereat and the needle retainer guide includes an aligned slot such that the toggle bar extends through the needle end slot and the needle retainer guide slot. The cam may take one of a variety of shapes. Essentially, the needle ends splay outward and forward, distally over the cam. In a preferred embodiment, the movable member is biased with respect to the central tube (that is, the first user actuation surface is biased with respect to the second user actuation surface) such that the delivery system is biased to place the needles in the proximal position and the needle ends are substantially captured in the needle retainer guides. In a further embodiment, the needle ends are longitudinally offset. In another embodiment, movable blades are disposed on the movable member, enabling the user to cut the suture threads during use of the suture delivery device. Another embodiment utilizes a flexible, elongated introducer at the distal end of the central tube. A method for embedding sutures in a vascular wall or other biological substructure is also included.